A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
- Registration Number
- NCT04408079
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
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Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
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Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.
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Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
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Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
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Has other malignant tumors in 2 years, except for cured or locally curable cancers.
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Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
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Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
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Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3558 Tablets TQB3558 TQB3558 tablets administered orally once. Then TQB3558 tablet administered orally, once daily in 28-day cycle after 4 days of first administration.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) up to 96 weeks Percentage of participants achieving complete response (CR) and partial response (PR).
Adverse events (AE) and serious adverse events (SAE) Baseline up to 28 days The occurrence of all adverse events (AE) and serious adverse events (SAE).
Maximum tolerated dose (MTD) Baseline up to 28 days MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
- Secondary Outcome Measures
Name Time Method AUC0-t 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11. To characterize the pharmacokinetics of TQB3558 by assessment of area under the plasma concentration time curve from zero to infinity.
Tmax 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11. To characterize the pharmacokinetics of TQB3558 by assessment of time to reach maximum plasma concentration.
Disease control rate（DCR） up to 96 weeks Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Progression-free survival (PFS) up to 96 weeks PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Duration of Response (DOR) up to 96 weeks DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Cmax 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11. Cmax is the maximum plasma concentration of TQB3558 or metabolite(s).
CL/f 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11. CL/f is total clearance rate for TQB3558.
Trial Locations
- Locations (1)
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China